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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Permanent
Location: Roscommon
REF: 96105
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Regulatory Affairs Specialist
Our client, a medical device company in Roscommon is currently looking to recruit a Regulatory Affairs Specialist for their site.

Quality system support
  • Change Control System / Document Control
  • Manage / Track change control, storage, release and distribution of all approved documents
  • Train personnel on change order process
  • Assist personnel with creating and/or processing change orders, including the completion of risk assessment and validation requirements
  • Manage and compile QA data for monthly Metrics review
  • Create, maintain and complete internal auditing schedule
  • Liaise with all departments to ensure continued corporate compliance
  • Support Management review and Management of external 3rd party audits.

Validation support
  • Provide Regulatory support to new product introduction and product transfers teams.
  • Ensures the biocompatibility requirements of the product are adequately addressed.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.

Regulatory Affairs Support
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same. Provide support with all international country submissions
  • Review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements.
  • Provide support to solve and reply to any regulatory query.
  • Help to manage and maintain all RA documentation including Technical Master File
  • Support all Product design and process changes requiring regulatory support

Operational Support
  • Provide ongoing regulatory support to help the team meet its business objectives.
  • Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs.

For further information on this Regulatory Affairs Specialist role in Roscommon please contact Bimi Felix on 086 8395533 /

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